Validation

Our validation group has extensive practical know-how on regulatory requirements (FDA/EMEA) and several local regulations. Commissioning and Qualification are performed at the vendor workshop and in Pharmadule's production facilities, resulting in a faster Commissioning and Qualification and final approval of the plant.

The work is performed according to a Commissioning Master Plan and a Qualification Master Plan. We work according to the current Good Manufacturing Practices (cGMP) for facility design, record keeping, personnel qualifications, sanitation, cleanliness, IQ (Installation Qualification), OQ (Operational Qualification), and complaint handling. The client performs the process and cleaning validation. Support is provided if needed.  

"Employees are highly educated and appear to be very conscientious. Appropriate QA unit oversight has been implemented during execution. Documentation associated with the Valudation^TM process is at the appropriate level to meet FDA expectations and does NOT appear to be either overly complex/detailed or of insufficient detail." (Second opinion from third party inspector, former FDA inspector from Quintiles)